II. Compliance Program Elements

The elements proposed by these guidelines are similar to those of the clinical laboratory model compliance program guidance published by the OIG in February 1997 (updated in August 1998), the hospital compliance program guidance published in February 1998, the home health compliance program guidance published in August 199812 and our corporate integrity agreements.13

The elements represent a guide that can be tailored to fit the needs and financial realities of a particular billing company, large or small, regardless of the type of services offered. The OIG is cognizant that with regard to compliance programs, one model is not suitable to every organization. Nonetheless, the OIG believes every billing company, regardless of size, structure or services offered can benefit from the principles espoused in this guidance.

The OIG believes every effective compliance program must begin with a formal commitment 14 by the billing company’s governing body to include all of the applicable elements listed below. These elements are based on the seven steps of the Federal Sentencing Guidelines.15 We believe every billing company can implement all of the recommended elements, expanding upon the seven steps of the Federal Sentencing Guidelines. The OIG recognizes full implementation of all elements may not be immediately feasible for all billing companies.

However, as a first step, a good faith and meaningful commitment on the part of the billing company administration, especially the governing body and the CEO, will substantially contribute to the program’s successful implementation. As the compliance program is implemented, that commitment should cascade down through the management to every employee in the organization. At a minimum, comprehensive compliance programs should include the following seven elements:

(1) The development and distribution of written standards of conduct, as well as written policies and procedures that promote the billing company’s commitment to compliance (e.g., by including adherence to the compliance program as an element in evaluating managers and employees) and that address specific areas of potential fraud, such as the claims submission process, code gaming and financial relationships with its providers; (2) The designation of a chief compliance officer and other appropriate bodies, e.g., a corporate compliance committee, charged with the responsibility of operating and monitoring the compliance program and who report directly to the CEO and the governing body; 16 (3) The development and implementation of regular, effective education and training programs for all affected employees; 17 (4) The creation and maintenance of a process, such as a hotline, to receive complaints and the adoption of procedures to protect the anonymity of complainants and to protect callers from retaliation; (5) The development of a system to respond to allegations of improper/ illegal activities and the enforcement of appropriate disciplinary action against employees who have violated internal compliance policies, applicable statutes, regulations or Federal, State or private payer health care program requirements; (6) The use of audits and/or other risk evaluation techniques to monitor compliance and assist in the reduction of identified problem areas;18 and (7) The investigation and correction of identified systemic problems and the development of policies addressing the non-employment of sanctioned individuals.

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